Adzenys ER

Product NDC
70165-003
11-digit product format
701650003
Labeler code
70165
Product ID
70165-003_c3cb469d-d045-c37f-e053-2a95a90a34cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Neos Therapeutics Brands, LLC
Application
NDA204325
Marketing category
NDA
Marketing start
2017-09-16
Marketing end
0000-00-00
Substance
AMPHETAMINE
Active strength
1 mg/mL
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70165-003-15ML - Milliliter70165-003b8a3461b-0992-4c70-abbe-f13bbad9504412018-02-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70165-003-1570165000315450 mL in 1 BOTTLE, GLASS (70165-003-15) 450 ml2017-09-160000-00-00NoNoCurrent